Package leaflet: Information for the user

BRODACID
Lactic acid + salicylic acid
(50.4 mg + 100 mg)/g
solution for skin
This medicine should always be used exactly as described in this leaflet or as directed by your
doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet:

What BRODACID is and what it is used for
Important information before using BRODACID
How to use BRODACID
Possible side effects
How to store BRODACID
Further information

1. WHAT BRODACID IS AND WHAT IT IS USED FOR

BRODACID is a topical solution containing the active substances salicylic acid and lactic acid.
Salicylic acid has a keratolytic effect; it softens and loosens the thickened outer layer of skin, facilitating its shedding.
Lactic acid is a caustic agent that destroys the keratinized layer of the skin.
The excipient dimethyl sulfoxide enhances penetration of the active ingredients into the tissue.

Indications
Treatment of common warts, periungual warts, plantar warts, and mosaic warts.

2. IMPORTANT INFORMATION BEFORE USING BRODACID: When not to use BRODACID

if you are allergic to the active substances—lactic acid or salicylic acid—or to any of the other ingredients of this medicine (listed in section 6),
for the treatment of flat warts or lesions located around the eyes, on mucous membranes, or on the face,
on pigmented moles (hairy or non-hairy),
on infected or inflamed skin,
during pregnancy and breastfeeding,
in children under 2 years of age.

Warnings and precautions
Before starting treatment with Brodacid, discuss it with your doctor, pharmacist, or nurse.
This medicine is for external use only.
Treatment should be discontinued if skin irritation occurs.
Protect the eyes, respiratory tract, and mucous membranes from contact with the medicine and its vapors. In case of accidental contact with eyes or mucous membranes, rinse immediately with plenty of water.
The medicine should be applied only to warts.
Do not apply the medicinal product to unchanged healthy skin or damaged skin, as salicylic acid may be absorbed through the skin, leading to systemic adverse effects of salicylic acid. If the medicine spreads to the healthy skin surrounding the wart, wash the area immediately with water.
In case of accidental ingestion, contact your doctor immediately.

Use in children
Do not use in children under 2 years of age.
In children aged 2 to 12 years, use only under medical supervision.

BRODACID with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Due to lack of studies on the use of this medicine in pregnant and breastfeeding women, it should not be used during pregnancy and breastfeeding.

Driving and operating machinery
BRODACID has no influence on the ability to drive motor vehicles or operate mechanical equipment.

3. HOW TO USE BRODACID MEDICINE

This medicine should always be used exactly as described in the patient leaflet, or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Apply the medicine to the wart using the applicator on a clean and dry surface. After unscrewing the cap and removing the applicator, wait a moment for the excess liquid to drain back into the bottle, then apply the liquid only to the surface of the wart, taking care to avoid contact with healthy skin, mucous membranes, or eyes.
After applying the medicine to the wart, wait a moment for the liquid to dry, forming a white film.
Apply twice daily to clean and dry skin. Apply only to the surface of the wart, depending on treatment response, for up to several days, maximally for 6–8 weeks.
Keep the bottle tightly closed; screw the cap on securely after each use.
Protect from evaporation.

Use in children
Do not use in children under 2 years of age.
In children aged 2 to 12 years, use only under medical supervision.

Use of a higher than recommended dose of BRODACID medicine
There is no data on overdose when the medicine is used according to indications and recommended application method.

Missed dose of BRODACID medicine
Do not use a double dose to make up for a missed dose.

Discontinuation of BRODACID medicine
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.
.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, BRODACID may cause adverse reactions, although not everybody experiences them.
Burning sensation and erosions with transient pigmentation may occur in the surrounding skin.
If extensive redness develops in the skin surrounding the application site, or any other adverse reactions occur, use of the medicine should be discontinued and a doctor should be consulted.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor, pharmacist, or nurse.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE BRODACID
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label.
Store below 25°C.
The medicine is flammable.
Due to its flammability, keep away from fire and sources of heat.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What BRODACID contains
The active substances in BRODACID are lactic acid and salicylic acid.
1 g of the skin solution contains 50.4 mg of lactic acid, in the form of 90% lactic acid solution, and 100 mg of salicylic acid.
The other ingredients are:

nitrocellulose (2:1) + ethyl acetate, dimethyl sulfoxide.

What BRODACID looks like and contents of the pack
BRODACID is a solution for topical application.
Pack:
A clear glass bottle containing 8 g of solution for skin with a polyethylene applicator and cap, placed in a cardboard box.

Marketing authorization holder and manufacturer
Marketing authorization holder: GRUPA INCO S.A.
ul. Wspólna 25
00 519 Warsaw
Manufacturer: Drug Production Department
ul. Ks. Kurowskiego 93
05 080 Izabelin Os. Hornówek

For further information, contact the representative of the marketing authorization holder:
Drug Production Department
05 080 Izabelin
tel. +48 22 722 89 01
fax. +48 22 722 89 00